The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy).

Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.

Other Name: PegIntron

Drug: raltegravir

HIV medication, 400 mg twice daily by mouth

Other Name: Isentress

Drug: Emtricitabine and tenofovir disoproxil fumarate

HIV medication, combination pill, once per day by mouth

Other Name: Truvada

Detailed Description:

We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure will be repeated.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adult Human

Able to provide written informed consent

HIV antibody positive

HIV viral load positive

HIV treatment naive

Hepatitis C antibody positive

Hepatitis C viral load positive

Hepatitis C treatment naive

Approved to take HIV medications for minimum 9 months

Willing to use contraception, Life expectancy greater than 2 years

Exclusion Criteria:

Significant opportunistic infections within 12 month

Hepatitis B positive

Evidence of liver cirrhosis

Decompensated liver disease

Chronic alcohol abuse

Allergy to raltegravir, tenofovir, and/or emtricitabine

Active or suspected malignancy

Sarcoidosis

Active TB

Coronary artery disease

Uncontrolled seizures

Untreated thyroid disease

Untreated diabetes

Weight greater than 125 kg

Severe depression or severe psychiatric disorder

Ongoing alcohol or illicit drug use

Pregnant, nursing, pr planning to become pregnant

Allergy to interferon

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285050